Closed loop electric breast pump

ABSTRACT

Examples disclosed herein are relevant to breast pumps. Disclosed examples include breast pumps that automatically adjust various pumping parameters based on data obtained from one or more sensors. The one or more sensors can produce data regarding an amount of milk expressed by a user. The adjusting of the pumping parameters can be configured to, for example, help the user efficiently express milk by utilizing a closed-feedback system that monitors the flow rate of the expressed milk.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/563,019, filed Sep. 6, 2019, which claims priority to U.S.Provisional Application No. 62/727,880, filed Sep. 6, 2018. Thedisclosure of these priority applications are hereby incorporated byreference in their entirety into the present application.

BACKGROUND

Capturing breast milk is beneficial for mothers who want to providetheir infants with natural breast milk. The term “milk” is used hereinto refer to liquid expressed by a human or animal breast, whichgenerally includes milk produced by mammary glands. Milk can includecolostrum, hindmilk, and foremilk. Breast pumps can be essential toolsfor mothers to capture milk for later use, which can be especiallyuseful for mothers that are traveling, working, or otherwise away fromtheir infants. Pumping is also useful to relieve engorgement and milkbuild up in the breast.

Breast pumps traditionally require the user to manually adjust theoperating parameters of the pump. A typical breast pump has two distinctmodes: the first mode is a stimulation mode to mimic the suckling of thebaby to cause the breast to release milk, which is also known as“letdown”. The second mode is an expression mode, where the pump createsa vacuum to facilitate the expression of milk into a container, such asa bottle. As used herein, “vacuum” need not refer to a perfect vacuumand instead encompasses a volume having a relatively low pressure (e.g.,relative to an environment outside of the volume). Switching betweenexpression and stimulation modes is currently typically performed eitherthrough a set timeout or from user input. Other settings that may beavailable for the user to manually change are vacuum pressure andwaveform speed. A primary difference between various breast pumps on themarket is the waveform used by the pump. Each mother is unique and wouldprefer one waveform over the other (and hence prefer one breast pumpover the other). It can be difficult for users to properly adjust thesemanual breast pump settings to quickly and comfortably achieving milkexpression.

SUMMARY

Technology disclosed herein relates to breast pumps. Disclosed examplesinclude breast pumps that automatically adjust various parameters of thebreast-pump waveform. The adjusting can be configured to, for example,help the mother efficiently express milk by utilizing a closed-feedbacksystem that monitors the flow rate of the expressed milk and totalvolume of milk expressed.

In an example, there is a breast pump system comprising: a milkcollection apparatus comprising a sensor configured to measure fluidwithin the milk collection apparatus; and a pump console. The pumpconsole can include a pump configured to induce suction at the milkcollection apparatus based on one or more pumping parameters and one ormore processors. The one or more processors can be configured to obtainfluid data from the sensor; and modify the one or more pumpingparameters based on the fluid data.

The milk collection apparatus can further include a breast shield, andthe sensor can be coupled to the breast shield. The system can furtherinclude a ring disposed around a portion of the breast shield of themilk collection apparatus, and the sensor can be coupled to the ring.The milk collection apparatus can further include a valve, and thesensor can be coupled to the valve. The breast pump system can furtherinclude a light source, and the sensor can include a light detector. Thelight source and the light detector can be arranged so that lightemitted from the light source passes through the valve to reach thelight detector. The milk collection apparatus can include a container,and the light source and the light detector can be arranged so thatlight emitted from the light source passes through the container toreach the light detector. The milk collection apparatus can furtherinclude a reflector, and the light source and the light detector can bearranged so that light emitted from the light source passes through thecontainer and is reflected by the reflector to reach the light detector.The sensor can include an electrode. The parameters include but notlimited to target pressure, rate of pressure increase, a ramp time, ahold time, a duty cycle, a release time, rate of pressure release or apumping waveform.

In another example, there is a breast pump system comprising: a milkcollection apparatus; a pump console comprising: one or more processorsand a pump, wherein the pump is configured to induce suction at the milkcollection apparatus based on one or more pumping parameters; and asensor configured to directly or indirectly obtain measurementsregarding the milk collection apparatus. The one or more processors canbe configured to: obtain data from the sensor; and modify the one ormore pumping parameters based on the data.

The milk collection apparatus can further include a breast shield, andthe sensor can be coupled to the breast shield. The milk collectionapparatus can further include a valve, and the sensor can be coupled tothe valve. The breast pump system can further include a light source,and the sensor comprises a light detector. The light source and thelight detector can be arranged so that light emitted from the lightsource passes through the valve to reach the light detector. The milkcollection apparatus can include a container, and the light source andthe light detector can be arranged so that light emitted from the lightsource passes through the container to reach the light detector. The oneor more processors can be configured to determine a change in the dataover time, and modifying the one or more pumping parameters can be basedon the change. The pump console can further include the sensor. Thesensor can be a pressure sensor. The one or more processors can beconfigured to determine a volume of milk within the milk collectionapparatus based on a pressure measured by the pressure sensor. Thesensor can be a current sensor configured to measure current draw of thepump, and the one or more processors can be are configured to determinea volume of milk within the milk collection apparatus based on thecurrent draw. The parameters can include a pressure, a ramp time, a holdtime, a duty cycle, release time, or a pumping waveform.

In another example, there is a method comprising: operating a vacuumpump of a breast pump system using one or more parameters; determining avolume of milk expressed as a result of the operation of the vacuumpump; and automatically modifying the one or more parameters based onthe determined characteristic.

Determining the characteristic of the milk can include measuring apressure with a pressure sensor. Operating the vacuum pump can includeoperating the vacuum pump through a cycle comprising a ramp period, ahold period, a release period, and a delay period. The release periodcan further include a first release period, a plateau period, and asecond release period and so-forth. The method can include determining amilk ejection pattern of a user of the breast pump system based on thevolume of milk expressed. Modifying the one or more parameters can bebased on the determined milk ejection pattern.

In yet another example, there is a milk collection apparatus thatincludes a breast shield for placement on a breast, a containerconfigured to receive milk expressed by the breast, a coupling conduitfor coupling the milk collection apparatus to a pump console, and asensor configured to measure milk within the milk collection apparatusand transmit data to the pump console.

The milk collection apparatus can further include a light source. Thesensor can include a light detector. The light source and the lightdetector can be arranged so that light emitted from the light sourcepasses through milk within the milk collection apparatus to reach thelight detector. The milk collection apparatus can further include a ringdisposed around a portion of the breast shield. The sensor can becoupled to the ring. The milk collection apparatus can further include avalve, wherein the sensor is configured to measure motion of the valve.The sensor can include an electrode.

BRIEF DESCRIPTION OF THE DRAWINGS

It is believed the present disclosure will be better understood from thefollowing description of certain examples taken in conjunction with theaccompanying drawings, in which like reference numerals identify thesame elements. The drawings are not intended to be limiting in any way,and it is contemplated that various embodiments can be carried out in avariety of other ways, including those not necessarily depicted in thedrawings. The accompanying drawings incorporated in and forming a partof the specification illustrate several aspects of the presentdisclosure, and together with the description serve to explain theprinciples of the disclosure; it being understood, however, that thescope of this disclosure is not limited to the precise arrangementsshown.

FIG. 1 illustrates an example breast pump system.

FIG. 2, which is made up of FIGS. 2A and 2B, illustrates an exampleimplementation of a milk collection apparatus.

FIG. 3, which is made up of FIGS. 3A, 3B, and 3C, illustrates an exampleoperation of a breast pump system.

FIG. 4 illustrates an example milk collection apparatus having one ormore sensors configured as electrodes.

FIG. 5 illustrates an example milk collection apparatus having one ormore sensors configured as optical sensors.

FIG. 6 illustrates an example milk collection apparatus having one ormore sensors attached proximate the breast shield

FIG. 7 demonstrates an example valve having a sensor.

FIG. 8, which is made up of FIGS. 8A and 8B illustrates an example milkcollection apparatus having a sensor configured as a magnetic sensor.

FIG. 9, which is made up of FIGS. 9A and 9B, illustrates an example milkcollection apparatus having a sensor configured as an optical sensor.

FIG. 10 illustrates the use of a mobile device with a camera as a sensorto capture an image of the container or another component of the milkcollection apparatus.

FIG. 11 illustrates the use of a weight sensor as a sensor to determinean amount of milk in the container.

FIG. 12 illustrates an example milk collection apparatus having a sleevehaving one or more sensors disposed thereon or therein to determine anamount of milk in the container.

FIG. 13 illustrates an example milk collection apparatus having a holderfor a container.

FIG. 14 illustrates an example milk collection apparatus having a sensorconfigured to measure deflection of the diaphragm.

FIG. 15 illustrates a waveform that can be used to control the operationof the pump.

FIG. 16 illustrates example breast pump waveforms.

FIG. 17 illustrates an example waveform.

FIG. 18 illustrates an example breast pump vacuum waveform withvibrational patterns added.

FIG. 19 illustrates four example categories of milk expression patterns.

FIG. 20 illustrates example instructions implementing a process.

DETAILED DESCRIPTION

Disclosed technology relates to breast pumps. Examples disclosed hereincan help breast pump users efficiently express milk by automaticallyadjusting various parameters of the breast pump. For example, thevolume, rate, or other parameters of milk expression can be directly orindirectly measured and pumping parameters can be modified basedthereon. Disclosed technologies include technology providing thecapability of a breast pump system to directly or indirectly obtainmeasurements (e.g., milk flow rate) via one or more sensors. Disclosedtechnologies further include technology for using the measurements toform a closed-loop system with the pump to optimize for desirablequalities (e.g., extraction time, comfort, and quietness). Theclosed-loop system can include a feedback loop between one or moresensors, one or more processors, and the pumping parameters.

Disclosed examples include various techniques for obtainingmeasurements, including: measuring milk with a flow sensor (e.g.,positioned proximate a breast shield of a milk-collection apparatus),measuring accumulated milk proximate a valve of the milk-collectionapparatus, measuring back-pressure on a diaphragm at the pump side as asurrogate of accumulated milk volume in the valve, and measuring aneffort of a vacuum pump (e.g., by measuring current draw or a dutycycle). Other techniques are also possible, including the use of sensorsto measure an accumulation of milk in a collection vessel and the use ofa pressure sensor in line with the vacuum pump.

Example sensors include one or more sensors associated with a breastshield, anterior chamber, valve, or container of the milk collectionapparatus. For example, the one or more sensors can include opticalsensors, electrical sensors, mechanical sensors, other kinds of sensors,or combinations thereof. An optical sensor can include an opticalemitter and an optical receiver. The amount of light blocked orotherwise affected (e.g., by milk, a distended nipple, or motion of avalve) can be used to directly or indirectly obtain measurementsregarding an amount of milk obtained or comfort of the user (e.g., wherethe optical sensor is configured to detect a distended nipple). Inanother example, the optical sensor can be a camera to obtain one ormore images that are analyzed to determine measurements (e.g., an amountof milk in a container). A mechanical sensor can be a flow meter thatdirectly or indirectly contacts the expressed milk to obtain flowmeasurements. An electrical sensor can include one or more electrodesextending along a nipple channel of a breast shield of the milkcollection apparatus. The one or more electrodes may be shielded toprevent or reduce disturbance from the outside environment (e.g., auser's hands). The one or more electrodes can measure a change incapacitance to determine milk flow rate or other characteristics (e.g.,nipple distention, which is correlated to nipple pain). As milk or anipple move proximate the electrode, a dielectric constant can beincreased, which results in a measurable increase in capacitance.

The one or more sensors used to obtain the data can be part of adiscrete component configured to couple with another component of thebreast pump system or the one or more sensors can be built into (e.g.,integral with) one or more components of the breast pump system. The oneor more sensors can be external to the components of the system and caninclude, for example, a smart bottle, an external scale, or a videocamera.

The data from one or more of the sensors can be obtained and used by oneor more processors to apply some type of corrective action, such as achange in parameters or an alert being provided to a user. The processorcan be within a pump console (e.g., a component that houses the pump) orexternal to the pump console. In some examples, a consumer device (e.g.,a smartphone, tablet, or laptop) can perform at least some of theprocessing and modify one or more parameters of a pump. The processorcan facilitate proper pressure being presented at the breast. Theprocessor can adjust the various parameters of the waveform and canmeasure the resulting effect on the milk flow rate. The system can takeinto account potential user discomfort when modifying parameters (e.g.,the parameters can be kept within safety or comfort tolerances). Thesystem can also take into account noise when modifying parameters (e.g.,to limit an amount of noise made by the system when in operation). Forexample, the pump can be configured to operate when vacuum ismaintained. This can be helpful for users that pump in the same room astheir baby, as a breast pump pumping while not attached to the breastcan be very loud. Likewise, if the breast shield is removed from thebreast, the breast pump system can detect the removal and canautomatically stop the pumping session. The technology herein canfurther facilitate determining whether the system is functioningproperly. For example, the system can determine vacuum loss within thesystem. As a result of detected vacuum loss, the pump can alert the userand potentially indicate where the pump system is not assembledcorrectly or if any components are not attaching well to each otherwithin the assembly. The processor can take into account an altitude atwhich the pump is operating and whether the user is using single pump ordouble pump system. While many examples herein are described in thecontext of a single milk collection apparatus being used, disclosedexamples can be applied to breast pump systems having two milkcollection apparatuses. In examples with multiple milk collectionapparatuses, different sensor data can be collected and differentparameters can be determined for each milk collection apparatus, sodifferences in milk expression on a breast-by-breast basis can bedetermined and accounted for (e.g., by having a different pumpingwaveform used by each breast). Alternatively, one or more sensors can beused to generate data and pumping parameters shared by each breast.

With the breast and breast pump acting as a closed-loop system, the rateof milk expression measured by the sensors or via another technique canbe a feedback signal based on which parameters can be changed tooptimize for increasing an amount of milk obtained during a session ordecreasing an amount of time taken to obtain a particular amount of milk(e.g., enough milk to fully empty a user's breast). The optimization caninclude optimizing for reduced hold time. To determine when the milkextraction has completed for that cycle, the system can measure the rateof change of pressure and when the rate is smaller than a threshold thebreast pump can then begin the release phase without delay (or withoutsubstantial delay). Improvements to milk extraction can be further basedon a particular milk expression pattern of the user. For example,research indicates that mothers can be categorized into four differentmilk ejection patterns, which are described in more detail in FIG. 20herein. See Kuroishi Sumiko, et al., “Study of Breast Pump Suction withVariable Rhythm Temporal Change in Breast Milk Flow and Mothers'Feelings”, Japanese Journal of Maternal Health, 59(3), 247 (2018), whichis hereby incorporated by reference herein in its entirety for any andall purposes. Further, some mothers express milk faster when the pumpwaveform is variable and others express milk faster when the waveform isconstant. Disclosed examples can allow the breast pump to automaticallydetermine which kind of waveform can express milk faster for aparticular user. For example, the rate of milk expression during use ofa constant waveform can automatically be compared against the rate ofmilk expression during use of a variable waveform.

In one example optimization technique, a PID (Proportional IntegrativeDerivative) loop is used that can include first and higher order PIDloops. To increase flow rate, the system can modify pumping parameters,such as by modifying pressure, ramp time, hold time, duty cycle, pumpingwaveform, other parameters, or combinations thereof. The system can alsouse any of a variety of machine-learning or artificial intelligencealgorithms (e.g., simulated annealing or genetic algorithms) tofacilitate processing the data or selecting parameters. Through the useof such techniques, parameters can be optimized for the particular userto improve, for example, a rate of milk expression. Where a PIDcontroller is used, the system can first ensure that the tunableparameters (e.g., rise time, hold time, pressure, and cycle time) are innegative feedback (e.g., a detected decrease in milk flow rate canresult in a proportional increase in pressure to attempt to increase themilk flow rate). The PID controller can attempt to maintain a targetmilk flow rate. The PID controller can also be set to maintain a targetpressure on the breast. For example, when the breast is emptied, theempty volume in the anterior chamber is increased, thereby decreasingoverall pressure to the breast.

The maximum rate at which pressure changes over a fixed time can be setby a parameter or by the pump motor itself. By driving the motor with apulse-width modulation, the rate at which the pressure rises over timecan be controlled. Disclosed examples can advantageously allow thesystem to determine whether a target pressure is reached. Absent aclosed feedback system, the target pressure can be achieved by runningthe motor at a 100% duty cycle for a fixed, pre-determined amount oftime found by trial and error, which can be difficult. With the closedfeedback system, the system can control the rise time and the targetpressure independently. The closed-feedback system can adjust the risetime rate by controlling the pulse width modulation, and stop runningthe motor once the target pressure is reached.

As described above, a breast pump system can include a variety ofcomponents acting as sensors that can produce data to control pumpingparameters to improve the function of the system. Breast pump systemscan come in any of a variety of configurations. An example breast pumpsystem that can operate as a closed-loop system is described in FIG. 1.

Breast Pump System

FIG. 1 illustrates an example breast pump system 100. The pump systemincludes two primary components connected by a tube 102: a milkcollection apparatus 110 and a pump console 120. Although the figureillustrates the milk collection apparatus 110 and the pump console 120being discrete components relatively remote from each other, they neednot be. In certain implementations, the breast pump system 100 can have,for example, the pump console 120 directly coupled to the milkcollection apparatus (e.g., the milk collection apparatus 110 and thepump console 120 can be part of a same housing or structure).

The milk collection apparatus 110 is a component of the breast pumpsystem 100 configured to apply suction to a breast to collect milk. Anexample implementation of the milk collection apparatus 110 is describedin more detail in FIG. 2. In the illustrated configuration, the milkcollection apparatus 110 includes one or more sensors 112. The sensors112 are described in more detail herein and can be configured to measuremilk within a flow path of the milk collection apparatus 110. The flowpath can include the path the milk takes from the breast to a containerof the milk collection apparatus 110. The data from the one or moresensors 112 can be transmitted to the pump console 120 for processingvia a wired or wireless connection 104. In addition to measuring milkwithin a flow channel, one or more of the sensors 112 can be configuredto determine, for example, whether a nipple has distended too farforward into the milk collection apparatus 110 (e.g., which may be anindicator of pain). The sensors 112 can be configured to not impede atraditional pumping workflow (e.g., cleaning, assembly, and use of abreast pump). Further, the sensors 112 can be configured to not come indirect contact with fluids or, if the sensors do come in contact withfluids, the sensors 112 can be biocompatible and easy to sterilize andclean.

The pump console 120 is a component of the breast pump system 100configured to induce suction in the milk collection apparatus 110. Inthe illustrated configuration, the pump console 120 includes a vacuumpump 122 coupled to the milk collection apparatus 110 via the tube 102.While typically referred to herein as a singular vacuum pump, the vacuumpump, the milk collection apparatus 110 can include multiple pumps 122and references herein to a single pump can be replaced with multiplepumps. An example implementation of the pump console 120 and itscomponents (including multiple pumps 122) is described in U.S.62/727,897, which is tilted “Multi-Pump Breast Pump”, and which ishereby incorporated by reference herein in its entirety for any and allpurposes. Other example implementations of the breast pump system 100are described in U.S. Pat. No. 8,545,438, which is titled “Breast Pump”and which is hereby incorporated by reference herein in its entirety forany and all purposes. The pump 122 and other components of the breastpump system 100 can be controlled by one or more processors 124.

The one or more processors 124 are one or more electronic componentsthat control one or more other components of the pump console 120. Theone or more processors 124 can, for example, control the function of thepump 122. The one or more processors 124 can be configured to obtaininput (e.g., from the one or more milk collection apparatus sensors 112and from the one or more pump console sensors 128), process the input,and take one or more output actions based thereon. The output actionscan include modifying parameters that the one or more processors 124 useto control components of the system 100. The one or more processors 124can include one or more microprocessors, application-specific integratedcircuits, field programmable gate arrays, other components, orcombinations thereof. The one or more processors 124 can obtain inputfrom the interface 130. The one or more processors 124 can be configuredto execute instructions stored in the memory 132 to perform operations.The processor 124 can modify parameters of the breast pump system 100 tofacilitate the expression of milk from the breast

The pump console 120 can further include a solenoid 126, one or moresensors 128, an interface 130, and memory 132.

The solenoid 126 is a component of the vacuum pump console 120 (or thepump 122 itself) configured to actuate a release valve to release someor all of the vacuum created by the vacuum pump 122. The solenoid 126can be controlled by the processor 124 to open, partially open, or closethe release valve.

The one or more sensors 128 are components of the pump console 120configured to generate data. In an example, the one or more sensors 128can include a pressure sensor configured to measure a pressure or amountof the vacuum created by the vacuum pump 122. In addition to or insteadof pressure sensors, the one or more sensors 128 can include timesensors, location sensors (e.g., GPS-based location), temperaturesensors, altitude sensors, humidity sensors, accelerometers, impedancesensors, light sensors, other sensors, or combinations thereof.

The interface 130 can include one or more components configured toreceive input or provide output. The interface 130 can include, one ormore components to receive input from a user (e.g., via one or moreswitches, buttons, touch interfaces, pointer devices, other components,or combinations thereof), provide input to a user (e.g., via one or moredisplays, lights, speakers, other components, or combinations thereof),and one or more components for communicating with other devices via awired (e.g., via an Ethernet connection, a serial interface connection,a parallel interface connection, other connections, or combinationsthereof) or wireless (e.g., via a radiofrequency connection, such asWI-FI, BLUETOOTH, other wireless radiofrequency connections, orcombinations thereof). Disclosed examples can further allow for new usercontrols for the breast pump as part of the interface 130. For instance,the processor 124 can be configured to detect a pressure change causedby a user squeezing a component of the milk collection apparatus 110(e.g., a breast shield thereof) and, in response, start or stop the pump122.

The memory 132 is a processor-readable storage media operable to storeinformation, such as data or instructions. The information stored on thememory 132 can be accessed and processed by the one or more processors124. The memory 132 can include random-access memory, read-only memory,programmable read-only memory (e.g., electronically-erasable programmingmemory), volatile memory, or non-volatile memory. The memory can use anyof a variety of technologies including, for example, optical, magnetic,spinning disk, or solid-state, among other technologies. The memory 132can include transitory or non-transitory computer readable mediums.

The milk collection apparatus 110 and the pump console 120 can beimplemented in any of a variety of forms. An example implementation ofthe milk collection apparatus 110 is described in FIG. 2.

FIG. 2, which is made up of FIGS. 2A and 2B, illustrates an exampleimplementation of a milk collection apparatus 110. As illustrated, themilk collection apparatus 110 can include a container 212 and a suctiontransfer assembly 216. The container 212 is a component for receivingmilk. The container 212 can take any of a variety of forms, such as abottle, syringe, bag, or other type of void space. The suction transferassembly 216 includes a breast shield 214 (which can also be referred toas a flange) for placement on a breast, as well as an anterior chamberdefined within a suction housing 218, a vacuum housing 220, a diaphragm222, and a valve 224. The diaphragm 222 can be a flexible membrane orother component separating an anterior chamber of the milk collectionapparatus 110 from a pump volume while still allowing pressure changesto be communicated across. Some implementations of the breast pumpsystem 100 can lack a diaphragm 222.

The valve 224 can be a component separating the anterior chamber fromthe container 212. The valve 224 can be a one-way valve, such as aduckbill valve. The valve 224 can take any of a variety of forms, suchas a flow restrictor valve, a spring driven valve, a hydraulic piston,or other types of pressure regulating valves. The suction transferassembly 216 can transfer pressure through the diaphragm 222. And thesuction transfer assembly 216 can include a coupling conduit 226 forcoupling the milk collection apparatus 110 to a pump console 120 formodifying the pressure. In some examples, the vacuum housing 220 caninclude or be configured as a pressure regulation feature. The pressureregulation feature can be adjustable by the user such that differentdimensions of pressure regulation features can be attached as the userdesires to provide for a higher or lower maximum vacuum dimensionallowed by the breast pump system 100. Additional details regarding anexample milk collection apparatus 110 are described in U.S. Pat. No.8,444,596, which is titled “Breast Milk Collection Apparatus andComponents Thereof” and which is hereby incorporated by reference hereinin its entirety for any and all purposes.

The milk collection apparatus 110 can cooperate with the pump console120 to cause milk expression from a breast placed in the breast shield214. An example operation of the breast pump system 100 is described inFIG. 3.

FIG. 3, which is made up of FIGS. 3A, 3B, and 3C, illustrates exampleoperation of the breast pump system 100. As illustrated, the breast pumpsystem 100 can define a pump volume 310, an anterior chamber 320, and acontainer volume 330. The anterior chamber 320 can be a volume at leastpartially bounded by a breast in which pressure is modified to stimulatethe breast and cause the expression of milk into the anterior chamber320. The anterior chamber 320 can be defined in part by the diaphragm222, which can separate the anterior chamber 320 from the pump volume310. The diaphragm 222 can be flexible such that pressure changes in thepump volume 310 affect the pressure of the anterior chamber 320. Forexample, the diaphragm 222 can contribute to a seal (e.g., a hermeticseal) that allows pressure changes in the pump volume 310 to becommunicated to the anterior chamber 320. The pump volume 310 is thevolume that the pump 122 directly affects in order to cause pressurechanges in the anterior chamber 320. The pump volume 310 can include aportion of the milk collection apparatus 110 that is “above” thediaphragm 222 (e.g., where the anterior chamber 320 can be considered“below” the diaphragm 222) as well as the tube 102 and a portion withinthe pump console 120 that includes the pump 122. The pump 122 can beactivated to reduce pressure in the pump volume, and a release valve(e.g., controlled by the solenoid 126) can be opened to allow pressurein the pump volume 310 to begin to equalize with a surroundingenvironment. The illustrated anterior chamber 320 is separated from thecontainer volume 330 via the valve 224. The valve 224 can be a one wayvalve (e.g., a duckbill valve) that allows fluid (e.g., air and milk) toflow into the container 212 but not to flow back into the anteriorchamber 320. Beneficially, this separation can allow for the anteriorchamber 320 to be substantially smaller than the volume that wouldtypically be necessary for collecting expressed milk during a pumpingsession. This smaller volume of the anterior chamber 320 is more easilyaffected by the pressure changes in the pump volume 310.

FIG. 3A illustrates a breast and nipple received within the breastshield 214. The pump 122 can receive a control signal from the processor124 that causes the pump 122 to activate to remove air from the pumpvolume 310 or otherwise reduce the pressure in the pump volume 310. Asthe pressure is reduced in the pump volume 310, the diaphragm 222deforms and causes a reduction in pressure in the anterior chamber 320,which induces suction at the breast.

FIG. 3B illustrates the change in pressure causing milk to be expressedin the anterior chamber 320 of the milk collection apparatus. The changein pressure can further cause the valve 224 to close and seal off theanterior chamber 320 from the container volume 330. As milk accumulatesin the anterior chamber 320, the milk displaces volume, which causes anincrease in pressure in the anterior chamber 320 and pushes thediaphragm 222 upwards. This increase in pressure caused by the milk canbe communicated to the pump volume 310 via the diaphragm 222 and sensedby a sensor (e.g., one or more sensors 112 or one or more sensors 128 ofthe breast pump system 100 as is described in more detail herein). Forexample, the pump console 120 can detect the pressure change to infer anamount of milk expressed, which can be used by the processor 124 to helpdetermine if letdown has occurred, if the breast is out of milk, or ifmore stimulation is possible. By integrating the accumulated milk ineach cycle, the pump console 120 (e.g., the processor 124 thereof) canestimate the total amount of milk pumped in the cycle and the session(which can include multiple cycles). A sensor can measure or infer achange in pressure as milk is expressed from the breast fills theanterior chamber 320 (e.g., prior to release of the pressure and openingof the valve 224 to allow the milk to flow into the container 212). Forexample, depending on the variation in pressure relative to power drawand or time, the breast pump system 100 can determine how the volume inthe anterior chamber changes and therefore correlate to how much milkhas been expressed into the anterior chamber 320 as a surrogate methodof determining milk flow.

FIG. 3C illustrates the release of pressure via the solenoid 126. Forexample, the processor 124 can send a control signal that causes thesolenoid 126 to at least partially open a release valve to reduce thevacuum (e.g., allow the pressure to increase) in the pump volume 310.The change in pressure in the pump volume 310 results in an increase inpressure in the anterior chamber 320, which allows the valve 224 toopen. The opening of the valve 224 allows the milk volume that wascollected in that cycle to drop into the container 212.

The operation cycle described in FIG. 3 can be repeated several timesuntil a desired amount of milk is expressed and collected in thecontainer 212. As described above, data obtained from sensors 112, 128or elsewhere can be used by the one or more processors 124 of the pumpconsole 120 to modify pumping parameters that can affect the ability ofthe system 100 to cause milk expression. For example, during theoperation cycle, pressure within the system 100 can be monitored andused to determine an amount of milk expressed.

Determining Milk Expression Using Pressure

As described above, the breast pump system 100 can define three primaryvolumes: the pump volume 310, the anterior chamber 320, and thecontainer volume 330. A measured pressure in the pump volume 310correlates to the volume of the anterior chamber 320. The restingpressure in the anterior chamber 320 can equal the resting pressure onthe pump volume 310. As the pump 122 is activated (e.g., with therelease valve closed and the valve separating the anterior chamber 320from the container volume 330 being closed), pressure decreases in thepump volume 310, which is communicated to the anterior chamber 320 viathe diaphragm 222, which results in milk extraction from the breast intothe anterior chamber 320. The extracted milk is temporarily confinedwithin the anterior chamber 320 because the valve 224 is closed. Thevalve 224 can remain closed during a hold period of the pump waveform.During the hold period, the hold pressure in the anterior chamber 320 isequal to the hold pressure in the pump volume 310. Based on the idealgas law (i.e., PV=nRT, where P is the pressure, Vis the volume, n is thenumber of moles, R is the ideal gas constant, and Tis the temperature),it can be assumed that temperature change is minimal and the displacedvolume by the breast during the hold period is constant. The extractedmilk constitutes a decrease in volume in the anterior chamber 320 by aΔy, which will result in an increase in pressure by ΔP in both theanterior chamber 320 and the pump volume 310. This increase in pressurecan be measured by an inline pressure sensor (e.g., sensor 128), whichcan correspond to the milk during the hold phase. The pressure sensorcan take any of a variety of forms, such as a MEMS(microelectromechanical systems) sensor, a deflection-based sensor, astrain-based sensor, a magnetic sensor, other sensors, or combinationsthereof. Since the system 100 can determine a waveform cycle period, theflow rate can be calculated. As the pump 122 transitions tovacuum-release, pressure in both the anterior chamber 320 and the pumpvolume 310 is equalized, the valve 224 opens allowing thetemporarily-confined milk to flow into the container volume 330, therebyresetting the system 100 to be ready to measure flow rate for a nextwaveform cycle.

Some implementations of a breast pump system 100 can lack a diaphragm222. In such examples, the pump 122 can directly affect the pressure inthe anterior chamber 320 without a diaphragm 222 communicating thepressure change. In such implementations, it can still be helpful todistinguish between the pump volume 310 (e.g., a volume from thecoupling conduit 226 to the pump 122) and the anterior chamber (e.g., avolume between the valve 224 and the coupling conduit 226), but ratherthan pressure changes being communicated via the diaphragm 222, thepressure changes in the pump volume 310 directly affect the pressure ofthe anterior chamber 320.

In some examples, during a stimulation phase where no milk is expressed,pressure in the pump volume can be measured using the sensor 128 toserve as a base measurement of pressure without milk present. Thepressure can be measured at different points in a waveform cycle andsignal processing can be used to measure the effects of the changedpressure (e.g., due to changes in volume in the anterior chamber 320)from the expressed milk. As there can be multiple letdowns within apumping session, the system 100 can use cycles within the first letdownas a baseline to optimize for future letdowns within a current sessionor future sessions by storing a pressure profile or tuned waveformparameters in memory for use during future letdowns. Signal processingcan include averaging pressure waveforms within one or more cycles(e.g., to create a running average) to increase a signal-to-noise ratio.Other methods include creating a model (e.g., a mathematical orstatistical model) using historical data of milk expression for theindividual user, where a function takes a pressure as input and producesa flow rate as output.

A more complicated signal processing method can use sigma-deltamodulation. The pump 122 can be driven using a pulse-width modulationsignal sent from the processor 124. A pressure provided by the pump 122can be affected by a duty cycle of the signal. Sigma-delta modulationcan be used to determine how long the pump 122 needs to be active tomaintain a set pressure (e.g., the duty cycle needed to maintain aparticular pressure in the pump volume 310 during a hold period). Sincethe pump volume 310 likely has at least some leakage, the pump 122 canbe active even during a holding period to maintain a set pressure. Asmilk is expressed into the anterior chamber 320, pressure increases,which can reduce the amount of time needed to turn the vacuum on tomaintain the set pressure. The amount of time the pump 122 is in an onstate (e.g., a change in the duty cycle needed to maintain pressure) canbe correlated to the amount of accumulated milk within the anteriorchamber for each cycle. A sigma-delta count can be used stand-alonemeasure or as an additional factor for an algorithm to increase theaccuracy of prediction for the milk flow rate or the total accumulatedvolume.

In addition to or instead of the use of pressure or pump 122characteristics, other sensors can be used to obtain data regarding apumping session. Example implementations of the sensors 112, 128 aredescribed in FIGS. 4-14.

Sensors

Various sensors can be used by the breast pump system 100 to obtain datausable to modify pumping parameters. An example sensor is an acousticsensor (e.g., disposed on the side of the container 212) that canindicate a change in the sound produced as milk begins to flow and dripfrom the valve 224 into the collection compartment. This change in soundcan indicate that letdown occurred and, in response thereto, theprocessor 124 can cause the pump 122 to switch from a stimulation phase(e.g., having a relatively rapid cycle) to an expression phase (e.g.,having a longer cycle time than the stimulation phase). A change insound can also indicate a reduction in flow rate. For example, thesensor 112 can take the form of a microphone configured to obtain soundindicative of milk flowing from the anterior chamber 320 to thecontainer 212. The sound obtained from the sensor 112 can be obtainedand analyzed, such that if the sound obtained from the sensor indicatesthat flow is relatively low or is decreasing at a particular rate, thenthe processor 124 can cause the pump 122 can begin a new stimulationphase.

Sensors can also be placed on or proximate the breast, which can allowthe pump system 100 to determine if the fluid retained in the breast isindicative of there being a potential for a second letdown with moreexpression of milk or if the breast is empty or near empty with littleadditional reason to continue pumping. Such sensors can also beconfigured to determine the amount of engorgement in the breast and theamount of milk remaining in the breast. An engorged breast tends to haveless breast movement when the vacuum is applied compared to anearly-empty breast. This breast movement can be detected by thepressure sensor and using an algorithm determine the amount of milkremaining in the breast. In some examples, an estimated amount of milkremaining in the breast can be used to determine a milk ejection patternof the user. In addition or instead, such data can be used to modifypumping parameters. Sensors can be, for example disposed at a portion ofthe breast shield 214 that is likely to contact breast tissue. Inaddition or instead, such sensors can detect if the user's skin isdehydrated, stiff, or otherwise indicative of too much or too littlefluid within the body. Such data can be used as an indication ofdehydration or low milk supply. With the information, the processor 124can predict the remaining time to fully express the milk from thebreast. Further, the determination can facilitate the user knowing ifthe breast is substantially empty, which can reduce the incidence ofmastitis.

Sensors can further include a location-determining sensors (e.g., viaGPS) for determining a likely altitude (and therefore a likelyatmospheric pressure). In addition or instead, systems can include anexternal pressure sensor to determine the atmospheric pressure directly.Examples can further include a clock or time-input mechanism, which canbe used to determine a current time of day. The time of day can be usedto recognize if a user is pumping in the morning, midday, evening,night, or any other time. The time of day can then be correlated to thepumping pattern for that user based on prior daily patterns of pumpingat those times. In some instances, longer suction waveforms can be usedto facilitate the expression of milk at later times of the day as moreretained milk is held in the back parts of the breast. Additionally,different times of the day can indicate different cycles of stimulationphase and expression which can be helpful to create more letdowns andproduce more milk. Wavelengths can be modulated in accordance with timeor any other variables incorporated into a processor to adjust thewavelengths of the pumping curve within a single pumping session or evenbetween pumping sessions at different times of the day or year. Inaddition, temperature sensors can be included in the system, such asambient air temperature sensors or skin temperature sensors as anindicator of receptivity to letdown or provide another parameter. Suchdata can also be used to determine which suction pattern should be usedby the breast pump system 100 given those environmental parameters(e.g., to encourage fast and comfortable pumping).

Other sensors for electrical impedance, capacitance, resistance,ultrasonic wave measurement, and or electrical nerve conduction or bloodflow can help determine if there is letdown, such that electricalsignals are firing which can be measured. Further, the opening of themilk ducts can be directly measured by changes in features such as butnot limited to diameter or dielectric constants.

Among the kinds of sensors that can be used are electrode-based sensors(see, e.g., FIG. 4, FIG. 7, and FIG. 14), optical sensors (see, e.g.,FIG. 5, FIG. 9, and FIG. 13), and magnetic sensors (see, e.g., FIG. 7),among others. The sensors 112, 128 can be disposed in any of a varietyof locations, such as proximate the breast shield 214 (See, e.g., FIGS.4-6), proximate the valve 224 (See, e.g., FIGS. 7-9), proximate thecontainer 212 (see, e.g., FIG. 12 and FIG. 13), proximate the diaphragm222 (See, e.g., FIG. 14), in other locations, or combinations thereof.In addition sensors that are separate from the milk collection apparatus110 and the pump console 120 can be used, such as via a consumercomputing device (see, e.g., FIG. 10) or a separate measuring device(see, e.g., FIG. 11). These examples implementations are described infurther detail in conjunction with FIGS. 4-14, below.

FIG. 4 illustrates an example milk collection apparatus 110 having oneor more sensors 112 configured as electrodes. In an example, theelectrodes can be configured as a capacitive flow meter with impedancesensing (both real and imaginary) from direct current to radiofrequency.In particular, the illustrated milk collection apparatus 110 includes asensor 112 that includes an excitation electrode 402 and a sensingelectrode 403. As illustrated, the electrodes 402 403 are disposedacross from each other along a fluid flow path of the milk collectionapparatus. In particular, the illustrated configuration shows theelectrodes 402, 403 disposed on or in the breast shield 214. In otherexamples, the electrodes 402, 403 can be disposed elsewhere, such asproximate the anterior chamber or the valve 224. The excitationelectrode 402 and the sensing electrode 403 can cooperate to generateand sense electric fields to measure fluid flow across a flow channel ofthe milk collection apparatus 110. For example, the presence of milk canaffect the electric field. The effects of the milk on the electric fieldcan be sensed and used to modify operation of the pump 122 or othercomponents of the breast pump system 100. As such, the electrodes 402,403 can cause a signal to be sent to the processor 124. The data can beused by the processor 124 to change pumping parameters (e.g., differenttypes of vacuum patterns, actuation levels, time scales, or oscillationpatterns).

In addition to or instead of the sensors 112 configured to detectproperties of milk flowing into the collection apparatus 110, thesensors 112 can also be configured to detect the presence of nipple orbreast tissue in the apparatus 110 and measure the distance the tissuedistends into the apparatus 110 when suction is applied.

FIG. 5 illustrates an example milk collection apparatus 110 having oneor more sensors 112 configured as optical sensors. In an example, theoptical sensors can be configured to provide an inline flow meter. Theone or more optical sensors 112 include one or more light sources 502and one or more photodetectors 503. The one or more light sources 502and one or more photodetectors 503 can cooperate to measure whether andto what extent material passes between the light sources 502 and the oneor more photodetectors 503. For instance, the one or more light sources502 can be configured as one or more visible or non-visible spectrumlight emitting diodes positioned on the breast shield 214, and the oneor more photodetectors can be positioned such that milk flowing throughthe collection apparatus 110 disrupts a signal measured by the one ormore photodetectors 503. The effect on the light received by thephotodetectors 503 can be measured to facilitate the measurement of anamount of milk or a milk flow rate. While the above example is describedin the context of visible light, non-visible wavelengths can be used inaddition to or instead of visible light.

FIG. 6 illustrates an example milk collection apparatus 110 having oneor more sensors 112 attached proximate the breast shield 214. Inparticular, the illustrated milk collection apparatus 110 includes anouter ring 603 having one or more sensors or detectors 602 disposed onor within the ring 603. The ring 603 can be disposed outside of a fluidflow path of the milk collection apparatus 110. The one or more sensorsand detectors 602 can be configured to generate light, electricalfields, magnetic fields, or other signals across a fluid flow path fordetection and use in detecting characteristics present in a fluid flowpath. In an example, the one or more sensors 112 can include magneticsensors, dielectric sensors, electrical field excitation sensors, photosensors, other non-contact external sensing mechanisms, or combinationsthereof. The sensors 112 can be used to sense the movement of fluidmagnitude and or timescale which would help the pump system 100determine how the system 100 is operating relative to the production ofmilk. The ring 603 can be detachable from the breast shield 614.

FIG. 7 demonstrates an example valve 224 having a sensor 112. Asillustrated, the sensor 112 is configured as an excitation electrode 702on one side of a flap opening of the valve 224 and a sensing electrode704 on a second side of the flap opening. When each these flaps areactuated or moved apart, milk can be detected and measured as it movesthrough the valve 224. In an example, the sensor 112 is configured tomeasure an amount of time or extent to which the valve is open, whichcan be used to determine an estimate of the volume or flow rate of fluidpassing through the valve 224. The sensor 112 can be configured as animpedance (resistive/capacitive/inductive) sensor. A signal from thesensor 112 can be transmitted to the pump console 120 to provide inputfor a software algorithm for use in determining operation of the breastpump system 100.

FIG. 8, which is made up of FIGS. 8A and 8B illustrate an example milkcollection apparatus 110 having a sensor 112 configured as a magneticsensor 811 disposed proximate a magnetic component 808 of the valve 224(e.g., the valve 224 can be a duckbill valve having at least two flapsand one or more of the flaps can have a magnetic component 808). Themagnetic sensor 811 can be configured to detect movement of the magneticcomponent 808. As the valve 224 actuates open and closed with flow ofmilk into the container 212, the magnetic component 808 can move, andthe movement can be detected with the magnetic sensor 811 to producedata. The produced data can be transmitted to the pump console 120 viathe transmitter 803. The magnetic sensor 811 can be disposed on or in acuff or top of the container 212. The magnetic sensor 811 can be incommunication with a transmitter 803 of the apparatus 110. Thetransmitter 803 is in wired or wireless communication with the pumpconsole 120. The magnetic component 808 can be magnetic, ferromagnetic,or metallic component that can affect the current and or voltage in anouter sensor ring such that as the valve 224 is manipulated to open orclose, the sensor 811 can provide a signal that (along with a timestamp)can be used to approximate the amount or magnitude of fluid or fluidpulses that enter the container 212.

FIG. 9, which is made up of FIGS. 9A and 9B, demonstrates an examplemilk collection apparatus 110 having a sensor 112 configured as a lightdetector 906. The valve 224 has transparent or semi-transparent sides902. The apparatus 110 includes a light source 904 configured totransmit a wavelength of energy or light through the valve 224 to thelight detector 906. The extent to which the transmitted wavelength ofenergy is affected as it passes from the light source 904 through thevalve 224 to the detector can be used to infer the presence of a milk inthe valve as well as the amount of milk therein. One or both of thelight source 904 and light detector 906 can be disposed proximate thevalve 224 via a ring 908. The ring 908 can be or attach to a cuff or topof the container 212. The ring 908 can further include a transmitter910. The transmitter 910 can be in wired or wireless communication withthe pump console 120. The data generated by the light detector 906 canbe provided to the transmitter 910 for sending the data to the processor124 via a wired or wireless connection for processing. Depending on thepower and wavelength emitted by the light source 904 and detected by thelight detector 906, the molecular composition, fat content, proteincontent, carbohydrate content, water content, nutritional content, othercontent, or combinations thereof of the milk in the valve 224 can bedetermined and recorded in real time as the milk passes through thevalve 224. This data can help inform the pump console 120, for example,if the milk is from the front of the breast (e.g., foremilk) or the backof the breast (e.g., hindmilk) with a varied fat and other nutrientcontent shift over time. In addition or instead, the data can relate tomovement of the valve 224, which can be used to infer an amount of fluidpassing through the valve.

FIG. 10 illustrates the use of a mobile device 1000 with a camera as asensor 112 to capture an image 1010 of the container 212 or anothercomponent of the milk collection apparatus 110. Video or image dataobtained from the camera can be analyzed to determine the fullness ofthe container 212. The data can also be used to determine a rate atwhich the container 212 is filling with milk. In an example, the image1010 can be analyzed using a machine-vision algorithm. In an example,the container 212 can include volume markings and a machine-visionalgorithm can be configured determine a volume marking most proximate tothe milk level in the container 212 to determine the amount of milk inthe container. In an example, the machine-vision algorithm is programmedusing the OPENCV library or another machine vision library. In additionor instead, the visual qualities of the milk can be analyzed todetermine properties of the milk (e.g., whether the milk is foremilk orhindmilk).

FIG. 11 illustrates the use of a weight sensor 1100 as a sensor 112 todetermine an amount of milk in the container 212. For example, thecontainer 212 can be placed on a scale or other weight sensor 1100. Thereading from the scale can automatically or manually be provided to theone or more processors 124 for modifying the pumping parameters.

FIG. 12 illustrates a milk collection apparatus 110 having a sleeve 1200having one or more sensors 112 disposed thereon or therein to determinean amount of milk in the container 212. The sensors 112 can include oneor more sensors as described herein, such as one or more electrical,magnetic, impedance, and or other sensors to determine the level offluid in the collection container. The sleeve 1200 is sized and shapedto couple with or fit around the container 212. In some examples, thesleeve 1200 can be built into the container 212. Alternatively, thesleeve 1200 can be discrete from the container.

FIG. 13 illustrates a milk collection apparatus 110 having a holder 1300for a container 212. The holder 1300 includes one or more light sources1310 and one or more light sensors 1320. The light produced by the lightsources 1310 can be transmitted through the container 212, reflected offof one or more reflectors 1330 and returns to be detected by the one ormore light sensors 1320. The light is modified as it passes through thecontainer 212 and any material contained therein. The properties of thereceived light can be analyzed to determine properties of the milk inthe container 212. The reflectors 1330 can be discrete reflectorcomponents disposed within a component of the apparatus 110.Alternatively the reflector 1330 can be a component of the apparatus 110having natural reflectivity. Although light is described, the source1310, the sensors 1320, and the reflectors 1330 can be configured tooperate using any of a variety of wavelengths of energy and need not belimited to the visible spectrum.

FIG. 14 illustrates an example milk collection apparatus 110 having asensor 112 configured to measure deflection of the diaphragm 222. Inexamples, an excitation electrode is disposed on the diaphragm 222 and adetection electrode is disposed on or within the vacuum housing 220 orvice versa. The rate and magnitude of deflection can be used todetermine the pressure relationship to milk in the anterior chamber 320of the apparatus 110 prior to the milk flowing through the valve 224into the container 212 when a source of suction is applied. Displacementof the diaphragm 222 can be measured using, for example, capacitance assurrogate to measure expressed milk flow rate by measuring increase anddecrease in capacitance as the diaphragm moves closer to the sensingelectrode and farther away from it with changes in pressure.

The data from one or more of the above sensors can be used to modifyoperation of the system 100. Further, the pump 122 or other componentsof the system 100 can act as sensors themselves. For example, thebehavior of the pump 122 (e.g., current draw, voltage, time needed toreach a target voltage, etc.) can act as a sensor itself and theproduced data can be used to infer information regarding milkexpression, pressure in the system, or other events. An example pumpwaveform that indicates an amount of milk expressed is shown in FIG. 15.

Determining Milk Expression Using Pumping Characteristics

FIG. 15 illustrates a waveform 1502 that can be produced by theprocessor 124 and used to control the operation of the pump 122. Theillustrated waveform 1502 a high signal corresponding to a motor oncondition and a low signal corresponding to a motor off condition of amotor of the pump 122. The duty cycle of the waveform 1502 can beexpressed as a percentage representing the relative amount time spent ina motor on condition compared to a motor off condition in a singlecycle. The waveform 1502 can be produced by the processor 124 to controlthe operation of the pump 122. Although illustrated as a square waveformhaving binary motor on and motor off states, the waveform 1502 can takeother forms, including sine, triangle, or saw tooth configurations.

The figure further illustrates how the properties of the waveform 1502can be analyzed to determine an amount of milk in the system. Forexample, the processor 124 can be configured to maintain a particularvacuum pressure, such as during a hold period (see, e.g., FIG. 16). Ifthere is expressed milk in the system (e.g., in the anterior chamberabove the valve 224), the free volume is reduced, so the pump 122 doesnot need to work as hard to maintain the pressure. This reduction ineffort can be seen in a relative amount of time spent in the motor oncondition per cycle compared to the amount of time spent in the motoroff condition of the cycle. As can be seen, less amount of time isneeded in the motor on condition to maintain the same pressure. As such,a difference in the amount of time can allow the system to determine thevolume in the anterior chamber, which can correlate to an amount of milkbeing present. In alternative examples, the relative amount of timespent in a motor on condition can be used across variable pressureexamples as well, such that the time, power, vacuum are measured andaccounted for.

In addition or instead of the relative amount of time being used, theamount of current consumed by the pump 122 or other pump 122 usagecharacteristics can be used as a measure to determine variousparameters, such as a milk flow rate, a volume of milk expressed, or apressure within the system. The pump can be driven in a closed-feedbackto maintain constant voltage across the pump, while measuring the amountof current consumed by the pump. If there is expressed milk in the valvesystem, the amount of current consumed will at least temporarilydecrease due milk occupying space in the anterior chamber volume makingthe pump 122 need to draw less current to cause a particular pressurechange in the anterior chamber. Thus the changes in the current draw ofthe pump 122 can be tracked and used to determine an amount of milkexpressed (e.g., by allowing the system to determine an amount of milkin the anterior chamber of each cycle).

Another technique can include the use of a feedback loop to drive themotor of the pump 122 at a constant voltage while measuring the currentconsumed by the motor. As milk accumulates in the anterior chamber, themotor does not need to work as hard to maintain the pressure, so thecurrent consumed during the waveform can be used as a surrogate measureof the amount of milk accumulated in the duckbill valve. This power orcurrent measurement can be used as stand-alone measure or as anadditional factor for the algorithm to increase the accuracy ofprediction for the milk flow rate and or the total accumulated volume.

Waveforms

FIG. 16 illustrates example breast pump waveforms represented over amultitude of vacuum waveforms 1601. The waveforms 1601 are shown interms of pressure over time. A first waveform 1602 is represented in asolid line and relates to a pump having a 100% duty cycle and 100%vacuum. A second waveform 1604 is represented with a long-dash line andrelates to a pump having a 100% duty cycle and 75% vacuum. A thirdwaveform 1606 is represented with a short-dash line and relates to apump having a 50% duty cycle and 75% vacuum. The pressure is relativepressure within a portion of the breast pump system compared to apressure of the environment outside of the breast pump system. Thefigure further shows a change in the waveforms 1601 over a cycle 1610.The cycle 1610 can be a discrete sequence of pump activity, such as canbe controlled by the processor 124 via the production of a waveform,such as the one shown in FIG. 15. The illustrated cycle 1610 includesdifferent periods, including a ramp period 1612, a hold period 1614, arelease period 1616, and a delay period 1618.

The ramp period 1612 is a period of decreasing pressure, such as causedby activating the vacuum pump 122. During the ramp period 1612, theprocessor 124 can send a control signal to the pump 122 to cause thepump to activate in such a way as to decrease pressure in a portion ofthe system. In examples, the ramp period 1612 can be a fixed period oftime or the ramp period 1612 can depend on an amount of time that thesystem takes to reach a particular pressure. A release valve (e.g., ascontrolled by the solenoid 126) can remain closed during the ramp period1612 to help maintain the relatively low pressure. The length of theramp period 1612 can relate to a relative vacuum level provided by thesystem, with a long ramp period 1612 resulting in lower pressure than arelatively shorter ramp period 1612. Thus, the ramp period 1612 candepend on a vacuum level setting. For example, as shown, the firstwaveform 1602 has a 100% vacuum (e.g., a maximum vacuum setting) leveland a relatively longer ramp period 1612 compared to the second waveform1604 and the third waveform 1606, which both have a vacuum level of 75%.The ramp period 1612 of the pump can affect the perceived comfort andperceived suction to the user. A very fast ramp period 1612 can give theuser the perception of a strong suction, even though the end pressuremay be the same as a relatively longer ramp period 1612. A slow rampperiod 1612 can result in more comfort to the user.

The delay period 1618 is a period following the ramp period 1612 andprior to the release period 1616, during which the pressure remainsrelatively low. The delay period 1618 can be a period of time duringwhich the pump 122 is inactive or during which the pump 122 operates ata reduced rate compared to the ramp period 1612. A release valve (e.g.,as controlled by the solenoid 126) can remain closed during the rampperiod 1612 to help maintain the relatively low pressure. As shown inFIG. 16, an amount of milk expressed during the hold period 1614 cancause a measurable change in pressure from the beginning of the holdperiod 1614 to the end of the hold period 1614. For example, thepressure in the anterior chamber of the milk collection apparatus canchange from nominal pressure to a higher pressure as a result of milkflowing into the chamber due to a reduction in the free air volume inthe chamber. This change in pressure can be detected and used to inferan amount of milk expressed. In examples, the hold period 1614 can befixed or independently controllable (e.g., the hold period 1614 need notvary based on vacuum level or duty cycle).

The ramp period 1612 and particularly the hold period 1614 are timeperiods during which a highest amount of milk is expected to beexpressed. Thus modifying the length of the ramp period 1612 (which canaffect a vacuum level used to express milk) and the length of the holdperiod 1614 can affect an amount of milk produced. While a low pressurecan cause more milk to be expressed, it can also cause discomfort forthe mother.

The release period 1616 is a period following the hold period 1614during which a vacuum in the system is allowed to be released such thatthe pressure increases relative to the pressure during the hold period1614. During the release period 1616, the pump 122 can be off and theprocessor 124 can send a signal to the solenoid 126 to cause a releasevalve to be opened. In examples, the release period 1616 can be fixed orindependently controllable (e.g., the release period 1616 need not varybased on vacuum level or duty cycle).

The delay period 1618 can be a period after the release period 1616 andprior to the end of the cycle 1610. During the delay period 1618 thepump 122 can be off and the solenoid 126 can cause the release valve tobe closed or open.

Between cycles 1610 or during cycles 1610 (e.g., during the delay period1618), the processor 124 can analyzed data collected regarding milkproduction during the periods and modify one or more parameters tooptimize milk production and comfort of the mother during future cycles.The changes can include, for example increasing the length of one ormore of the periods. Relatively shorter cycles can be selected forletdown stimulation and relatively longer cycles can be selected forexpression of milk. For example, while the measured amount of milk isrelatively low (e.g., has not yet satisfied a threshold), the processor124 can control the pump 122 to provide letdown stimulation and milkproduction satisfies a threshold, the processor 124 can modify pumpingparameters to provide expression stimulation. As described elsewhereherein, various features or characteristics can be imparted intowaveforms by the pump 122 as the processor 124 detects and adapts touser preferences from input signals on other measurement devices.

FIG. 17 illustrates an example waveform 1702. Like waveform 1602, thewaveform 1702 includes a vacuum ramp period 1612, a hold period 1614,and a delay period 1618. Unlike the release period 1616 of the waveform1602, the waveform 1702 includes a release period 1720 having a firstrelease period 1722, a minor partial vacuum plateau period 1724, and asecond release period 1726. The first and second release periods 1722,1726 can have properties similar to the release period 1616. The minorpartial vacuum plateau period 1724 can be a time period during which thepressure does not substantially increase. For example, while a releasevalve can be open during the first release period 1722, the releasevalve can be closed at the start of the plateau period 1724. The plateauperiod 1724 can be imparted into the waveform 1702 by an adaptiveprocess (e.g., a software algorithm) of the pump console that adjuststhe waveform 1702 in accordance with sensor feedback from the pump 122to extract milk. The waveform 1702 can be cycled again or followed byother kinds of waveforms.

FIG. 18 illustrates an example breast pump vacuum waveform 1802 withvibrational patterns added. As with FIG. 17, this waveform 1802 includesa cycle 1710 having a vacuum ramp period 1612, a first hold period 1614,a first release 1722, a minor partial vacuum plateau period 1724, asecond release period 1726, and a delay period 1618. The vibrationalpattern can be added by, for example, the processor 124 causing thesolenoid 126 to repeatedly open and close the release valve. While therelease valve, the pump 122 can be deactivated to conserve energy. Andas illustrated, during the hold period 1614, plateau period 1724, anddelay period 1618, while the pump 122 may typically be disabled, thepump 122 can be activated to return pressure to a relatively steadystate.

Additional example waveforms that can be used are described in U.S.62/727,909, which is tilted “Vibratory Waveform for Breast Pump”, andwhich is hereby incorporated by reference herein in its entirety for anyand all purposes. The configuration of the waveforms and the cyclesprovided by the system 100 can be configured to match particular milkexpression patterns of the users. Example milk expression patterns aredescribed in more detail in FIG. 19.

Milk Expression Patterns

FIG. 19 illustrates four example categories of milk expression patterns.Different users can express milk in different patterns. The technologydescribed herein can be used to identify to which category the mombelongs and optimize the pumping waveform based thereon. For example,the system can switch between stimulation and expression mode to reducethe total breast pumping time.

As illustrated, a category A user can typically experience a first andonly letdown after approximately 240 seconds of pumping. Then the userwill empty most of her breast within the next 60 seconds. So to optimizepumping for this kind of user, the system can operate in a stimulationmode for approximately 240 seconds (or until milk expression isdetected). Then the system can switch to an expression mode. Once theamount of milk expressed drops below a threshold amount, then the pumpcan indicate pumping is complete.

A category B user can typically experience a small letdown within thefirst sixty seconds, and then have another letdown every approximatelytwo minutes thereafter, with the user's breast being fully empty withinapproximately six minutes. To optimize pumping for this user, the system100 can operate in a stimulation mode for approximately sixty seconds(or until milk expression is detected) and then operate in an expressionmode until the amount of milk expressed drops below a threshold amount.Then the system can switch back to the stimulation mode and repeat theprocess for a certain amount of time (e.g., six minutes) or until theamount of milk expressed while operating in an expression mode dropsbelow a threshold.

A category C user tends to have a relatively continuous letdown and canrequire approximately ten minutes to empty her breast. Thus, the systemcan optimize pumping for this user by providing a stimulation mode,switching to an expression mode once milk expression is detected andcontinue to operate in the expression mode until the milk expressiondrops below a threshold.

A category D user can have a relatively large letdown within the firstminute and have small letdowns every subsequent two minutes and willrequire approximately ten minutes to empty most of her breast. Tooptimize for a category D user, the system can start in stimulation modefor the first minute and switch to expression once the pump detects milkexpression. Once the amount of milk expressed drops below a threshold,the pump can will switch back to stimulation mode. This process can berepeated for 5 times to ensure that breast milk is emptied from thebreast.

The system can detect to which category the user belongs based onanalyzing a cumulative amount of weight or flow rate of the user overtime and comparing the results to known categories (e.g., by fitting acurve corresponding to a category to the flow rate and/or weight). Inother examples, the system can receive input from the user indicating towhich category the user belongs. The system can then store categoryinformation and operate according to the user's category.

An overall example process for operating the breast pump system 100 isdescribed in FIG. 20.

Example Process

FIG. 20 illustrates example instructions 2000 implementing a process2002. Although shown as being implemented with instructions 2000, theoperations of the process 2002 can be performed using one or morecircuits configured to perform operations without needing instructions2000 to be executed. The process 2002 can begin with operation 2010. Insome examples, the process 2002 can begin responsive to the pump console120 being powered on or the system detecting that a user pressed a startbutton.

Operation 2010 includes operating the breast pump system 100 usingparameters. The parameters include the parameters described herein andcan correspond to values stored by the pump console 120 and used by theprocessor 124 to control operation of the pump system 10.

In an example, the two primary components used to operate the breastpump system are the pump 122, which creates a vacuum within the systemand the solenoid 126, which releases the vacuum. Both the pump 122 andthe solenoid 126 can be controlled via signals from the processor 124.The processor 124 can generate such signals based on a wide variety ofparameters.

The parameters that can be changed include length of the cycle 1710,length of the ramp period 1612, length of the hold period 1614, lengthof the release period 1616, length of the delay period 1618, maximumpressure level, maximum vacuum level, minimum pressure level, minimumvacuum level, vibration patterns, presence of plateaus during the cycle1600 (see, e.g., FIG. 17), slope of pressure changes over time duringthe ramp period 1612 or release period 1616, other features orcombinations thereof.

Parameters can exist at relatively high and relatively low levels, withsome parameters controlling the values of other parameters. For example,the pump can have a parameter that specifies a particular phase ofpumping in which the breast pump system 100 is operating. For instance,the breast pump system 100 selectively operate in a stimulation phase oran expression phase. The stimulation phase can be a phase configured tostimulate a breast to produce milk and the expression phase can be aphase configured to facilitate the extraction of milk once milk beginsto be expressed in the stimulation phase. The phase in which the breastpump system 100 operates can affect other parameters. For example, astimulation phase can have relatively shorter waveform cycles and theexpression phase can have relatively longer waveform cycles as specifiedby one or more different parameters associated with each type of phase.Following operation 2010, the flow of the process 2002 can move tooperation 2020.

Operation 2020 includes obtaining data from one or more sensors. Thisoperation 2020 can include the processor 124 receiving data from one ormore sensors 112 of the milk collection apparatus 110, one or moresensors of 128 the pump console 120, other sensors, or combinationsthereof. The data can include measurements directly or indirectlyobtained by the one or more sensors regarding the milk collectionapparatus. For example, a sensor 128 within the pump console 120 can beused to measure a power draw of the one or more pumps 122, which can beused to measure an amount of milk in the milk collection apparatus 110.In this example, while the sensor 128 directly measures power draw ofthe one or more pumps 122, the obtained measurements themselves can beused by the processor 124 to measure an amount of milk in the anteriorchamber 320 of the milk collection apparatus 110. Thus, the sensor 128can be considered to directly measure power draw and indirectly measurethe amount of milk because the amount of milk is correlated to the powerdraw. In some examples, this operation 2020 includes receiving datapushed from the sensors, in other examples, this operation 2020 caninclude sending requests for data from the sensors. The operation 2020can include determining characteristics of expressed milk, such as milkflow rate or volume. The operation 2020 can include causing the sensorsto obtain data. Following operation 2020, the flow of the process 2002can move to operation 2030.

Operation 2030 includes modifying the parameters based on the obtaineddata. The operation 2030 can include modifying the parameters directlybased on the obtained data, or the operation 2030 can include processing(e.g., analyzing) the obtained data and using the processor 124 andmodifying the parameters based on the processing.

In an example, the processing includes comparing at least some of thedata with a threshold and, responsive to the threshold being satisfied,modifying one or more parameters. In many examples, the modifying isperformed based on whether and to what extend the obtained dataindicates the production of milk. This can include data indicating avolume of milk collected or a rate at which milk is being collected. Asdescribed above, the modifying of the parameters can be configured tostimulating a breast to express milk, obtain milk from the breast oncemilk is expressed, and then stop pumping once a sufficient amount ofmilk has been expressed. The modifying can be based on real-time dataobtained from the sensors. The modifying can be further based oncomparisons of current data with previous data stored in the system(e.g., stored in the memory 132).

The processing can be based on, for example, statistical analysis. Insome examples, the processing is based on changes in data over time,such as a rate of change in pressure, current draw, estimated flow rate,or other data obtained by or inferred from the sensors. In someexamples, the processing can be performed with a machine learningalgorithm trained to produce output based on data provided as input. Forexample, any of a variety of machine-learning or artificial intelligencealgorithms can be used, such as simulated annealing or geneticalgorithms. To use those algorithms, each of the various parameters arerandomly adjusted simultaneously in each cycle, and the uniqueparameters to each individual person that influence the rate ofexpression are found. For example, the algorithms can be trained in realtime on how the change in parameters affect the volume of milk produced.Over time, the algorithms become customized to the particular user.

In an example, a genetic algorithm can be used. Tuning of parametersusing a genetic algorithm can occurs over one or more sessions. In anexample implementation, various parameters are initially randomly chosenand constitute the search space (which can be constrained by comfort andsafety) defined as Session S1. A parameter from the search space for S1can be chosen for each cycle or for n-amount of cycles, and the flowrate is measured. For the next Session S2, the top-n parameters thatresult in the highest flow rates are selected for breeding the nextgeneration of parameters for Session S2. For the n settings, the systemcan randomly generate nC2 pairs between the parameters. For each pair(e.g., corresponding to a father and mother), i children will berandomly generated with each child will having half of its parametersfrom the father and half from the mother. Which parameters from themother and the father that gets passed down to the children can be atleast pseudorandom. These children constitute the search space forSession S2. At the completion of Session S2, the top-n parameters thatresulted in the highest flow rate for this session can be selected forbreeding the next generation of parameters for Session S3. As such, thesystem can learn from the user over multiple sessions. The search spaceand performance for each setting can be stored in memory the device orat an external location (e.g., a removable memory device, a mobiledevice, at a server, or another location) and can be unique to eachuser. The system can also generate an aggregate model from many users,to create a model that can work decently well for a subset of users. Forexample, one hundred users can use different pumps simultaneously, andthe system can leverage the parallel users to iterate through the searchspace much faster to generate a generalizable model. This allows thesystem to search in a larger search space, which can allow for not onlyrise time, pressure, hold time, delay, but also unique waveforms aswell. Models can be shared between pumps to generate a generalizablemodel via a network (e.g., the Internet, via BLUETOOTH, or anothercommunication medium).

Following operation 2030, the flow of the process 2002 can return tooperation 2010.

Although this detailed description has set forth certain embodiments andexamples, the present disclosure extends beyond the specificallydisclosed embodiments to other alternative embodiments and/or uses ofthe embodiments and modifications and equivalents thereof. Thus, it isintended that the scope of the present disclosure should not be limitedby the particular disclosed embodiments described above.

1. A breast pump system comprising: a milk collection apparatuscomprising a pump volume; a pump console comprising one or moreprocessors and a pump, wherein the pump is configured to induce suctionat the milk collection apparatus based on one or more pumpingparameters; and a pressure sensor configured to measure negativepressure within the pump volume, wherein the one or more processors areconfigured to: control the pump through one or more milk expressioncycles, wherein each of the one or more milk expression cycles includesat least one period; detect, using the pressure sensor, a change from afirst negative pressure measured during the at least one period of afirst milk expression cycle of the one or more milk expression cycles toa second negative pressure measured during the at least one period of asecond milk expression cycle of the one or more milk expression cycles;and modify at least one of the one or more pumping parameters, based atleast in part on the detected change from the first negative pressure tothe second measured pressure.
 2. The breast pump system of claim 1,wherein the milk collection apparatus further comprises a breast shield,and wherein the pressure sensor is directly attached to the breastshield.
 3. The breast pump system of claim 1, wherein the pump consolefurther comprises a current sensor, wherein the current sensor isconfigured to measure current draw of the pump, and wherein the one ormore processors are configured to modify at least one of the one or morepumping parameters, based at least in part on a measured current draw.4. The breast pump system of claim 1, wherein the one or more pumpingparameters are selected from the group consisting of a ramp time, a holdtime, a duty cycle, a release time, and a pumping waveform.
 5. Thebreast pump system of claim 1, wherein the one or more processors arefurther configured to: determine a milk ejection pattern for a user ofthe breast pump system based on a volume of milk expressed; and modifyat least one of the one or more pumping parameters based on thedetermined milk ejection pattern.
 6. The breast pump system of claim 5,wherein modifying the at least one of the one or more pumping parametersbased on the determined milk ejection pattern comprises modifying astimulation parameter.
 7. The breast pump system of claim 5, whereindetermining the milk ejection pattern comprises determining a flow rateof a volume of milk expressed over time.
 8. The breast pump system ofclaim 1, wherein the at least one period for each of the one or moremilk expression cycles comprises a ramp period, a hold period, and arelease period.
 9. The breast pump system of claim 1, wherein the atleast one period comprises a hold period.
 10. A breast pump systemcomprising: a milk collection apparatus; a pump; a current sensorconfigured to measure a current draw of the pump; a voltage sensorconfigured to measure a voltage draw of the pump; and one or moreprocessors configured to: control the pump to induce suction at the milkcollection apparatus based on one or more pumping parameters; and modifyat least one of the one or more pumping parameters based on current drawand the voltage draw of the pump.
 11. The breast pump system of claim10, wherein the one or more processors are further configured todetermine a reduction in an amount of effort expended by the pump, andwherein determining the estimated volume of milk accumulated within themilk collection apparatus is determined based on the reduction in theamount of effort, thereby being based on the current draw.
 12. Thebreast pump system of claim 10, further comprising a pump consolecomprising the pump, the current sensor, and the one or more processors.13. The breast pump system of claim 10, further comprising a pressuresensor configured to measure a negative pressure within the pump volume,wherein the one or more processors are further configured to detect achange in the negative pressure within the pump volume.
 14. The breastpump system of claim 13, further comprising a pump console including thepump, the pressure sensor, and the current sensor.
 15. The breast pumpsystem of claim 13, wherein the change in the negative pressure isselected from the group consisting of a change within the cycle and achange between the cycle and another cycle.
 16. The breast pump systemof claim 13, wherein the cycle is a milk expression cycle.
 17. Thebreast pump system of claim 13, wherein modifying at least one of theone or more pumping parameters includes transitioning from stimulationpumping parameters to expression pumping parameters or transitioningfrom expression pumping parameters to stimulation pumping parameters.18. A breast pump system, comprising: a milk collection apparatuscomprising a pump volume; a pump console comprising one or moreprocessors and a pump, wherein the pump is configured to induce suctionat the milk collection apparatus based on one or more pumpingparameters; and a pressure sensor configured to measure negativepressure within the pump volume, wherein the one or more processors areconfigured to: control the pump through a milk expression cycle thatincludes at least one of a hold period or a release period; detect,using the pressure sensor, a change in negative pressure measured duringat least one of the hold period or the release period; determine anestimated volume of milk within the milk collection apparatus, based onthe detected change in negative pressure; and record the estimatedvolume of milk.